Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Nilotinib
Drug ID BADD_D01567
Description Nilotinib, also known as AMN107, is a tyrosine kinase inhibitor under investigation as a possible treatment for chronic myelogenous leukemia (CML). A Phase I clinical trial in 2006 showed that this drug was relatively safe and offered significant therapeutic benefits in cases of CML which were found to be resistant to treatment with imatinib (Gleevec), another tyrosine kinase inhibitor used as a first-line treatment for CML.
Indications and Usage For the potential treatment of various leukemias, including chronic myeloid leukemia (CML).
Marketing Status approved; investigational
ATC Code L01EA03
DrugBank ID DB04868
KEGG ID D08953
MeSH ID C498826
PubChem ID 644241
TTD Drug ID D00STL
NDC Product Code 71796-047; 54893-0069; 0078-0526; 0078-0592; 0078-0951
UNII F41401512X
Synonyms nilotinib | 4-methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide | nilotinib hydrochloride dihydrate | benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride, hydrate (1:1:2) | nilotinib hydrochloride anhydrous | benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride (1:1) | nilotinib hydrochloride | nilotinib hydrochloride hydrate | Tasigna | nilotinib hydrochloride monohydrate | benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride, hydrate | nilotinib hydrochloride sesquihydrate | benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride, hydrate (2:2:3) | nilotinib dihydrochloride dihydrate | benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride, hydrate (1:2:2) | AMN107 | AMN-107 | AMN 107
Chemical Information
Molecular Formula C28H22F3N7O
CAS Registry Number 641571-10-0
SMILES CC1=C(C=C(C=C1)C(=O)NC2=CC(=CC(=C2)C(F)(F)F)N3C=C(N=C3)C)NC4=NC=CC(=N4)C5=CN=CC= C5
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Spinal pain17.10.01.020; 15.02.01.008; 08.01.08.0300.000582%Not Available
Eye colour change06.06.06.0080.000246%Not Available
Diabetic metabolic decompensation14.07.03.003; 05.07.03.0030.000112%Not Available
Chronic myeloid leukaemia recurrent01.10.07.003; 16.01.07.0030.000951%Not Available
Internal haemorrhage24.07.01.0720.000392%Not Available
Cerebral vascular occlusion24.04.06.035; 17.08.01.0490.000112%Not Available
Vascular stent stenosis24.04.02.028; 08.07.05.0070.000224%Not Available
Appendicitis noninfective07.08.03.0180.000112%Not Available
Bell's palsy17.04.03.011--Not Available
Cardiac dysfunction02.11.01.0040.000168%Not Available
Cerebellar stroke24.04.06.046; 17.08.01.0700.000168%Not Available
Coronary artery dilatation24.03.04.012; 02.02.01.0190.000112%Not Available
Coronary ostial stenosis02.02.01.020; 24.04.04.0310.000112%Not Available
Dilated cardiomyopathy02.04.01.0170.000168%Not Available
Disease complication08.01.03.0870.000437%Not Available
Endocrine ophthalmopathy06.09.04.008; 05.02.02.008; 14.11.01.051; 10.04.08.0120.000112%Not Available
Gait inability17.02.05.069; 08.01.02.0110.001343%Not Available
Giant cell arteritis24.12.02.003; 17.08.02.033; 10.02.02.032; 06.07.02.0100.000224%Not Available
Graves' disease10.04.08.014; 06.09.04.009; 05.02.02.0090.000168%Not Available
Hair growth rate abnormal23.02.06.0120.000112%Not Available
Heavy menstrual bleeding21.01.03.005--Not Available
Hydrocholecystis09.03.02.0130.000112%Not Available
Hyperaesthesia teeth07.09.06.005--Not Available
Hyperleukocytosis01.02.01.0180.000112%Not Available
Iliac artery stenosis24.04.03.0250.000392%Not Available
Illness08.01.03.091--Not Available
Immune thrombocytopenia10.02.01.083; 01.08.01.0130.000336%Not Available
Intercostal neuralgia17.02.07.0250.000112%Not Available
Left atrial enlargement02.04.02.0420.000224%Not Available
Left ventricular dilatation02.04.02.0440.000112%Not Available
The 34th Page    First    Pre   34 35    Next   Last    Total 35 Pages
ADReCS-Target
Drug Name ADR Term Target
Tip:  Drug Name  ADR Term  Protein  Variation  Gene